Niquitin

Package leaflet: Information for the user

NiQuitin, 2 mg lozenges
Nicotinum
NiQuitin, 4 mg lozenges
Nicotinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
You should always use this medicine exactly as described in this patient leaflet or as your
doctor, pharmacist or nurse has advised.

• Keep this leaflet. You may need to read it again.
• If you need advice or additional information, please consult your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
• If you do not get better or if you feel worse, you should contact your doctor.

Contents of the leaflet

1. What NiQuitin is and what it is used for
2. What you need to know before using NiQuitin
3. How to use NiQuitin
4. Possible side effects
5. How to store NiQuitin
6. Contents of the pack and other information

1. What NiQuitin is and what it is used for

NiQuitin lozenges for Nicotine Replacement Therapy (NRT) reduce nicotine craving and withdrawal symptoms in people dependent on nicotine, regardless of the method of use of this substance. Nicotine dependence may result from smoking tobacco, inhaling vapours containing nicotine (vaping), or absorption of nicotine through the cheek from oral products such as nicotine pouches or other nicotine-containing products.
The medicinal product NiQuitin lozenges is indicated as an aid to immediate smoking cessation or gradual discontinuation of nicotine use prior to complete cessation of the habit, and to enable temporary abstinence, e.g. when the use of nicotine products is not permitted. The medicinal product NiQuitin lozenges may also be used to reduce cigarette and other nicotine product consumption in individuals who do not plan to quit nicotine use immediately.
In justified cases, NiQuitin patches and oral dosage forms may be used in combination. Whenever possible, NRT should be used in conjunction with a behavioural support programme, which increases the likelihood of successful nicotine cessation.
The aim of therapy is complete cessation of nicotine use.

2. Important information before using NiQuitin

When not to use NiQuitin

• if the patient is allergic to nicotine or any of the other ingredients of this medicine (listed in section 6)
• in children and adolescents under 18 years of age;
• in non-smokers or those who do not use e-cigarettes or nicotine pouches;
• in individuals with hypersensitivity to peanuts or soya.

Warnings and precautions
Exercise special caution in the following cases:

• uncontrolled hypertension,
• impaired kidney or liver function,
• pheochromocytoma,
• hyperthyroidism,
• cardiovascular disorders (e.g. stable angina, heart failure, cerebrovascular disorders, conditions involving vasoconstriction, severe peripheral vascular disease),
• individuals who have ever experienced seizures should consult a doctor, pharmacist, or nurse before using this medicine.
• gastric or duodenal ulcer or oesophagitis, as swallowed nicotine may worsen disease symptoms,
• hospitalization due to myocardial infarction, severe cardiac arrhythmia or stroke, patients should attempt to quit smoking, vaping, or using nicotine products without nicotine replacement therapy, unless otherwise advised by a physician. After discharge from hospital, nicotine replacement therapy may be continued as before. If clinically significant increase in blood pressure occurs or other nicotine-related adverse effects appear, the dose should be reduced or treatment with NiQuitin discontinued.

There is a risk of dependence during treatment with this medicine.
Diabetic patients should monitor their blood glucose levels more frequently than usual during treatment, as requirements for insulin or other antidiabetic medications may change.
Patients with phenylketonuria: NiQuitin tablets contain a source of phenylalanine and may be harmful to individuals with phenylketonuria.
If a patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Keep out of sight and reach of children.
NiQuitin with food and drink
Do not eat or drink while sucking on the tablet.
Important information for patients on a low-sodium diet
1 NiQuitin tablet contains 15 mg of sodium. This should be taken into consideration in patients who are monitoring their sodium intake.
NiQuitin and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Pregnancy, breastfeeding and fertility
Pregnant women, women planning to become pregnant, or those who are breastfeeding should try to stop smoking without using NiQuitin tablets. If quitting smoking is unsuccessful, these women should consult their doctor.
Driving and operating machinery
The effect of this medicine on the ability to drive and operate machinery is unknown.

3. How to use NiQuitin

This medicine should always be used exactly as described in the patient information leaflet or as
advised by your doctor, pharmacist, or nurse. If in doubt, consult your doctor,
pharmacist, or nurse.
Dosage:
Adults (aged at least 18 years)
NiQuitin 2 mg is suitable for smokers who smoke 20 or fewer cigarettes per day,
users of e-cigarettes using liquids with a concentration <12 mg/ml (1.2%), and users of
nicotine pouches with strength <10 mg.
NiQuitin 4 mg is suitable for smokers who smoke more than 20 cigarettes per day,
users of e-cigarettes using liquids with a concentration >12 mg/ml (1.2%), and users of
nicotine pouches with strength >10 mg.
Behavioural counselling and support usually improve the success rate of treatment.
Immediate cessation of smoking, nicotine vaping, or use of oral nicotine pouches
(or other nicotine-containing products)
Individuals using NiQuitin should make every effort to completely stop
smoking cigarettes, vaping, or using nicotine pouches during treatment
with this product.
The following treatment schedule should be followed:

From week 1 to week 6, it is recommended to use at least 9 pastilles per day.
Do not use more than 15 pastilles per day.
Treatment with nicotine pastilles may last longer than 24 weeks, if necessary, to remain abstinent from smoking cigarettes, using vaporizers, or using nicotine pouches.
Patients using pastilles for longer than 12 months should consult a healthcare professional.

Gradual smoking cessation, nicotine vaping, or use of nicotine pouches (or other nicotine-containing products):
For smokers, users of vaporizers, or users of oral nicotine pouches and other nicotine-containing products who do not wish to, or are unable to, immediately quit their habit.
Take a pastille whenever a strong urge to smoke, vape, or use a nicotine pouch arises, in order to reduce as much as possible the number of cigarettes smoked or the amount of nicotine consumed, and to delay smoking, vaping, or using nicotine pouches for as long as possible.
The number of pastilles used per day varies and depends on the patient's needs. However, do not use more than 15 pastilles per day.
If after 6 weeks of treatment the patient has not reduced cigarette smoking or nicotine intake from vaporizers or nicotine pouches, they should consult a physician.
Reducing consumption should lead to complete cessation of smoking, vaping, or using nicotine pouches. The goal should be achieved as quickly as possible. Once the number of cigarettes smoked, frequency of vaping, or use of nicotine pouches has been reduced to a level at which the user feels ready to quit completely, they should begin the dosing regimen intended for "abrupt smoking cessation" described above.
If a complete cessation attempt is not made within 6 months of starting treatment, consultation with a physician is recommended.

Reducing smoking, nicotine vaping, or use of nicotine pouches (or other nicotine-containing products):
For smokers, users of vaporizers, or users of oral nicotine pouches who wish to reduce use of nicotine products without plans for immediate cessation of the habit.
Take a pastille whenever a strong urge to smoke, vape, or use an oral nicotine pouch arises, in order to reduce as much as possible the number of cigarettes smoked or the amount of nicotine consumed, and to delay smoking, vaping, or using nicotine pouches for as long as possible. Users should be encouraged to quit smoking, vaping, or using nicotine pouches completely as soon as possible.
The number of pastilles used per day varies and depends on the patient's needs. However, do not use more than 15 pastilles per day.
If after 6 months from the start of treatment the user still feels the need to regularly use pastilles and has still not attempted to quit the habit permanently, it is recommended that they seek additional help and advice from a physician.

Temporary abstinence:
Take one pastille every 1–2 hours to manage troublesome withdrawal symptoms, including nicotine cravings. Users should not take more than 15 pastilles per day.
Users should be encouraged to quit smoking, vaping, or using nicotine pouches completely as soon as possible. If after 6 months from the start of treatment the user still feels the need to regularly use pastilles and has still not attempted to quit the habit permanently, it is recommended that they seek additional help and advice from a physician.

Combined Nicotine Replacement Therapy (NRT):
In some cases, it may be beneficial to use more than one form of NRT simultaneously.
Combined therapy may be used, for example, by smokers, users of vaporizers, or users of oral nicotine pouches who have previously relapsed while using a single NRT product, or if nicotine cravings persist despite NRT use, or if difficulties arise in controlling the urge to smoke or use another nicotine-containing product during monotherapy.
Smokers, users of vaporizers, or users of oral nicotine pouches may combine transdermal patches with oral nicotine products (chewing gum, pastilles, etc.). The combination of transdermal patches and oral nicotine is more effective than using transdermal patches alone.
Treatment should begin by determining the patch dose used in combination with the oral nicotine dose.
Treatment with NiQuitin patches should generally begin with the NiQuitin 21 mg dose, which should be reduced according to the following schedule:

Dose Duration
Step 1: NiQuitin 21 mg First 6 weeks
Step 2: NiQuitin 14 mg Next 2 weeks
Step 3: NiQuitin 7 mg Final 2 weeks

For moderate smokers (e.g., smoking fewer than 10 cigarettes per day), users of vaporizers using nicotine liquids with concentration below 6 mg/ml (0.6%), and users of nicotine pouches with strength < 6 mg, it is recommended to start therapy at Step 2 (14 mg) for 6 weeks, then reduce the NiQuitin product dose to 7 mg during the final 2 weeks.

Recommended daily use of oral products in combination with patches is approximately 5–6 units. When using combined therapy, the maximum daily dose of 4 mg oral formulations is 10 units, and for 1.5 mg/2 mg oral formulations, the maximum is 15 units.

Recommended dosing for combined therapy:

For heavier smokers (e.g., smoking more than 10 cigarettes per day, users of vaporizers using nicotine liquids with concentration above 6 mg/ml (0.6%), and users of nicotine pouches with strength > 6 mg):

| Period | Patches* | Oral nicotine dose |
|-----------|---------------|--------------------------|
| | | chewing gum/pastille 2 mg/4 mg |
| | | or mini pastille 1.5 mg/2 mg/4 mg |
| Step 1: 6 weeks | nicotine 21 mg/24 hours | Average: 5–6 units/24 hours** |
| Step 2: 2 weeks | nicotine 14 mg/24 hours | Continue using oral formulations as needed** |
| Step 3: 2 weeks | nicotine 7 mg/24 hours | Continue using oral formulations as needed** |
| After 8–10 weeks | Discontinue patches | Gradually reduce number of oral formulations used. When daily intake is limited to 1–2 units, discontinue treatment. |

*Depending on number of cigarettes smoked or amount of nicotine consumed per day (see above).
**Smokers consuming more than 20 cigarettes per day, users of vaporizers using nicotine liquids with concentration >12 mg/ml (1.2%), and users of nicotine pouches with strength >10 mg should use the 4 mg dose for the first 6 weeks. Then switch to a lower-dose oral product. Maximum daily dose of 4 mg oral formulations is 10 units, and for 1.5 mg/2 mg oral formulations, the maximum is 15 units.

For lighter smokers (smoking 10 or fewer cigarettes per day, users of vaporizers using nicotine liquids with concentration below 6 mg/ml (0.6%), and users of nicotine pouches with strength < 6 mg):

| Period | Patches* | Oral nicotine dose |
|-----------|---------------|--------------------------|
| | | chewing gum/pastille 2 mg |
| | | or mini pastille 1.5 mg/2 mg |
| Step 1: 6 weeks | nicotine 14 mg/24 hours | Average: 5–6 units/24 hours** |
| Step 2: 2 weeks | nicotine 7 mg/24 hours | Continue using oral formulations as needed** |
| After 8–10 weeks | Discontinue patches | Gradually reduce number of oral formulations used. When daily intake is limited to 1–2 units, discontinue treatment. |

*Depending on number of cigarettes smoked or amount of nicotine consumed per day (see above).
**Maximum daily dose of 1.5 mg/2 mg oral formulations is 15 units.

Duration of treatment depends on individual needs. Generally, oral nicotine NRT products are used for 2–3 months, after which the dose should be gradually reduced. Treatment should be discontinued when the patient is using 1 to 2 pastilles per day.

Method of administration
Place one pastille in the mouth and allow it to dissolve. From time to time, move it from one side of the mouth to the other until it dissolves completely (approximately 20–30 minutes). Do not chew or swallow the pastille whole.
Avoid eating or drinking while the pastille is in the mouth.

Use of a higher than recommended dose of NiQuitin
If too many NiQuitin pastilles are taken, symptoms such as pallor, cold sweats, salivation, vomiting, abdominal pain, diarrhea, headache, dizziness, hearing and vision disturbances, tremors, confusion, and weakness may occur. Discontinue use of the medicine and consult a doctor or pharmacist immediately.

Missed dose of NiQuitin
If a dose is missed, take the next pastille as soon as possible. Do not use two pastilles at the same time to make up for the missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The adverse effects listed below are grouped according to their frequency of occurrence:

Very common (affecting more than 1 in 10 patients)

• nausea

Common (affecting less than 1 in 10 but more than 1 in 100 patients)

• vomiting, dyspepsia, abdominal pain, diarrhoea, dry mouth, constipation, hiccups, oral inflammation, flatulence, oral discomfort, heartburn, oral irritation or ulceration
• headache, dizziness
• insomnia, restlessness, increased appetite
• sore throat, cough, throat and larynx pain

Uncommon (affecting no more than 1 in 100 people)

• peptic ulcer, gastroesophageal reflux, hiatus hernia, oesophagitis, dry throat, toothache
• local numbness, taste disturbances
• low mood, increased anxiety, nightmares, hunger sensation, mood changes
• laryngospasm, asthma, lower respiratory tract infections, nasal or throat irritation, nasal congestion
• coagulation disorders and associated bleeding (bleeding from gums and nose)
• skin redness
• rash, itching, skin eruption, local skin reactions, increased sweating
• jaw pain
• nocturnal enuresis
• overdose effect, leg pain, leg swelling

Very rare (affecting less than 1 in 10,000 people)

• severe allergic reactions such as sudden shortness of breath or chest tightness, skin rash and feeling faint.

Adverse effects with unknown frequency

• palpitations, tachycardia (increased heart rate), rapid and irregular heartbeat (atrial fibrillation)
• difficulty swallowing, belching, regurgitation (passive movement of stomach contents into the oesophagus), excessive salivation, ulcerative stomatitis
• weakness, fatigue, malaise, influenza-like symptoms
• hypersensitivity, angioedema (breathing difficulties or swelling of lips, tongue, throat or face), urticaria
• tremor
• seizures
• nervousness
• dyspnoea
• unusual dreams

If any adverse effects occur, including any possible adverse effects not listed in this leaflet, consult a doctor, pharmacist or nurse.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: 22 49-21-301, fax: 22 49-21-309
website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Niquitin

Store below 25°C, in the original packaging. The medicine should be kept
in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
If you have any questions or doubts, consult your doctor or pharmacist.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What NiQuitin contains
The active substance is nicotine. Each tablet contains 2 mg or 4 mg of nicotine (in the form of
nicotine polacrilex).
The other ingredients are: mannitol (E421), sodium alginate (E401), xanthan gum (E415),
potassium hydrogen carbonate (E501), anhydrous sodium carbonate, aspartame (E951), magnesium stearate,
peppermint flavour (containing maltodextrin and modified starch).

What NiQuitin looks like and contents of the pack
NiQuitin is a white or almost white, round tablet supplied in blisters. The cardboard carton contains 12, 24, 36, or 72 tablets in blisters.

Marketing Authorisation Holder and Importer:
Marketing Authorisation Holder:
Perrigo Poland Sp. z o.o.
ul. Domaniewska 48
02-672 Warsaw
tel. +48 (22) 852 55 51

Importer:
Perrigo Supply Chain International Designated Activity Company
The Sharp Building
Hogan Place
Dublin 2
Signature Not Verified
Dublin, D02 TY74, Ireland
Document signed by Anna Czubaj
Date: 2026.03.23 16:50:46 CET